Secondary endpoints analysis in patients with estrogen receptor-positive metastatic breast cancer treated with everolimus and exemestane enrolled in Oral Care-BC

Abstract

Background The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients who received POC to those who had not, and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE. Methods Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated for both the groups over 8 weeks by an oncologist. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months. Results There were no significant differences in PFS between the POC and Control Groups (P = 0.801). A BMI < 25 mg/m2 and non-visceral metastasis were associated with longer PFS (P = 0.018 and P = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS (P = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial. Conclusions POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI < 25 mg/m2, and who did not receive BMA while receiving EVE and EXE may have better prognoses. Trial registration The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov (NCT02376985).

Postdiagnosis body fatness, weight change and breast cancer prognosis: Global Cancer Update Program (CUP global) systematic literature review and meta‐analysis

“…However, studies adjusted at least for age, tumor stage, cancer treatment, and either comorbidities or smoking, on average, showed positive associations. Consistent positive associations were also observed among the secondary analysis of clinical trials 45 , 48 , 54 , 59 , 63 , 64 , 68 , 70 , 88 , 102 , 103 , 104 , 106 , 116 , 120 , 121 , 123 , 147 , 159 , 161 , 162 , 164 , 181 , 191 , 193 , 199 , 203 , 211 , 221 , 222 , 238 , 252 , 253 , 283 which were expected to have better treatment protocols and management. The evidence of greater body fatness causing increased mortality was unlikely to be caused solely by chance or bias, and was graded as strong probable evidence.…”

“…The meta‐analyses included 101 publications reporting postdiagnosis BMI (assessed from at‐diagnosis to on average 5.8 years postdiagnosis), waist circumference (at‐diagnosis to 7.9 years postdiagnosis), waist‐to‐hip ratio (at‐diagnosis to 2.5 years postdiagnosis) and pre‐ to postdiagnosis weight gain or loss (from 1 year before to 1 year or more after diagnosis) 27,39‐138 . In addition, 119 publications were descriptively synthesized…”

Study of prevalence and risk factors of chemotherapy-induced mucositis in gastrointestinal cancer using machine learning models

“…Both primary and secondary endpoints were analyzed as described previously ( 18 ). The accuracy of the TPM model was in ML-TPM setting was assessed as described previously ( 19 ).…”

Radix Actinidia chinensis Suppresses Renal Cell Carcinoma Progression: Network Pharmacology Prediction and In Vivo Experimental Validation

“…At present, the treatment options for RCC patients are very limited besides surgery [ 4 ]. It is reported that targeted biologics, such as tyrosine kinase inhibitor [ 5 ] and rapamycin inhibitor [ 6 ], have exhibited certain clinical efficacy for RCC. Nevertheless, these mentioned biologics easily produce drug resistance and negative adverse effects [ 7 ].…”